MRI Safety
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Catalog excerpts

MRI Safety - 1

MRI Safety The Denali® Vena Cava Filter was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005. Non-clinical testing demonstrated that the Denali® Vena Cava Filter is MR Conditional. A patient with this implant can be scanned safely immediately after placement under the following conditions: • Static magnetic field of 3-Tesla or 1.5-Tesla Spatial gradient magnetic field of 720-Gauss/cm or less Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 2-W/kg in the normal operating mode In non-clinical testing, the Denali® Vena Cava Filter produced a temperature rise of 2.7°C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3-W/kg for 15-minutes of continuous MR scanning in a 3-Tesla MR system using a transmit/receive body coil (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI). MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Denali® Vena Cava Filter. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant may be necessary. Artifact Information: Image artifact of the Denali® Filter was tested according to ASTM F2119-07 in a GE HDx 3-Tesla cylindrical bore scanner. The greatest artifact occurred at the snare hook and the ends of the arms and legs with the static field parallel to the length. The maximum extent of the artifact beyond the metal of the phantom was 5 mm for the spin echo sequence and 10 mm for the gradient echo sequence. Imaging parameters may need to be adjusted for artifact optimization. It is recommended that patients with a vena cava filter register the MR conditions with the MedicAlert Foundation (www.medical

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MRI Safety - 2

Denali® Vena Cava Filter The Denali® Vena Cava Filter should not be implanted in: The Denali® Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: • Patients with an IVC diameter larger than 28 mm. Bard and Denali are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners. • Pregnant patients when fluoroscopy may endanger the fetus. Risks and benefits should be assessed carefully. Copyright © 2013, C. R. Bard, Inc. All...

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